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Senior Manager, GMDP Audits

Princeton, New Jersey

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Summary:

The Senior Manager, GMDP Audits conducts audits, including but not limited to external suppliers (CDMOs, DS manufacturers, batch release sites, warehousing and transportation service providers, distributors, etc), internal manufacturing sites, commercial affiliates, as well as other entities as applicable, according to KK standards. This includes routine, for cause and due diligence audits.

Essential Functions:

•    Performs GMP/GDP due diligence audits, globally. 
•    Performs, as lead auditor or coauditor, GMP/GDP audits, including but not limited to external suppliers (CDMOs, DS manufacturers, batch release sites, warehousing and transportation service providers, distributors, etc), internal manufacturing sites, commercial affiliates, as well as other entities as applicable. 
•    Evaluates Audit responses and oversees tracking mechanism for GMP/GDP audits and manages CAPA as per KK standards.
•    Provides input to the annual risk-based audit plan, Schedule and execution of audits based on changing business environment and interaction with cross-functional teams. 
•    Provides ongoing feedback to management on potential quality-related risks
•    Supports (and may lead) process improvement initiatives, develops/administers SOPs, as well as maintenance of other controlled documents in the quality document management systems.
•    Participates in Health Authority inspection activities (both domestic and international, as applicable).
To keep abreast with regulatory compliance requirements and clinical developments in the GMP, GDP and GQP areas through personal development and training, becoming an SME for Kyowa Kirin in these areas.

Requirements:

Education
-    Life Science degree or equivalent (preferably in Pharmacy, Chemistry or Microbiology). 

Experience
-    5 years' (minimum) experience of working within the pharmaceutical industry's manufacturing, of which at least 3 should have involved Quality Assurance work and/or GMP/GDP auditing. Aseptically manufactured parenteral products experience is required. 
-    Excellent working knowledge of the basic principles of pharmaceutical quality, quality assurance, manufacturing process quality.

-    Sound knowledge of the regulatory requirements, science and manufacture behind pharmaceutical dosage forms (e.g. oral solid and semi-solid dosage forms, oral liquid and intravenous sterile / aseptically-manufactured products) 

Technical Skills
Proficient in MS Office Suite

Non-Technical Skills
Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

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Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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